The Regents of the University of California, San Francisco (UCSF) has been awarded a $250,000 Cooperative Agreement from the U.S. Food and Drug Administration (FDA) under the FDA Research program (CFDA 93.103). The purpose of this award is to fund UCSF's continued work on qualifying bone mineral density (BMD) as a surrogate endpoint for fracture in future clinical trials of anti-osteoporosis therapies.
The project, known as the SABRE (Study to Advance BMD as a Regulatory Endpoint) initiative, aims to obtain formal FDA qualification of BMD change as a surrogate endpoint that can be used to expedite the development of new medications for osteoporosis. This would represent a significant breakthrough, as it would enable smaller and shorter clinical trials focused on BMD changes rather than the costly, lengthy fracture outcome trials currently required. If successful, this would facilitate innovation and the introduction of new safe and effective osteoporosis treatments, providing major benefits to public health.
Generated 1/28/25, 9:40 AM